AnemiaNCT01224535
Improving Iron Status of Children: Potential of Amaranth
A study testing Maize and Amaranth in people with Anemia and Iron Deficiency Anemia, run by Wageningen University at 1 site in Kenya.
Trial summary
Introduction: Iron deficiency anaemia remains a significant public health challenge. Localized food based approaches may offer a large opportunity to improve lives and address the widespread micronutrient deficiencies such as iron in affected households. Read more about this study
- Who is it for?
- Ages 12 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency Anemia
- What is being tested?
- Maize and Amaranth
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteKenya
- Study dates
- Oct 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 12-59 months at the time of entry into the study
- Resident in village for at least 6-months and the caretaker plans to remain in the area for the next year
- Apparently healthy at the time of entry into the study
Who cannot join
- Severe anaemia i.e. Hb concentration <70 g/L (See section 5.5)
- Taking iron containing haematinic supplements
- Transfused in the last six months
- Severely undernourished i.e. anthropometric indices <-3 Z score
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Iron Status of Children in a Semi-arid Area of Kenya: the Potential of Amaranth Grain Flour
Introduction: Iron deficiency anaemia remains a significant public health challenge. Localized food based approaches may offer a large opportunity to improve lives and address the widespread micronutrient deficiencies such as iron in affected households. Viable solutions where iron rich foods are not readily available may come through diversification approaches using foods such as amaranth grain reported to contain high iron content and good quality protein in conjunction with the use of in-home fortification.
Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on improving diet quality, iron intake and status in children 12-59 months in a semiarid area in Kenya.
Read more
Study population: The study population will comprise children aged 12-59 months in Migwani, within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed on behalf of the children. In total, 270 children will be enrolled in the study.
Study design:
The study has a randomized controlled trial design conducted over a period of 4 months/16 weeks.
Treatment/hypothesis: All participating children will be required to take the provided porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant difference in hemoglobin and iron status between the three groups.
Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive protein (CRP) will be done at the participating laboratories.
Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are the secondary outcome. Iron deficiency will be defined as SF concentration <12 µg/L and tissue iron deficiency will be defined as serum transferrin receptor concentration of >8.3mg/L. Infection will be assessed by raised CRP (>10mg/L) as an indicator of acute inflammation and presence of malaria.
Read the detailed description
Background and Rationale The most severe problems of micronutrient deficiency are found amongst resource poor, food insecure and vulnerable households in developing countries. From the 1999 Kenya national survey on micronutrients, it was estimated that seven out of every ten children under five years are likely to be anaemic (Hb<110g/L) and nearly half (43.2%) were iron deficient.
The period of complementary feeding is a critical and vulnerable time in the growth and development of children. Poor complementary feeding practices combined with chronic food insecurity are found to substantially contribute to the widespread multiple micronutrients deficiencies in developing countries.
A recent food consumption study in Mwingi district in Kenya, showed that ugali (stiff maize porridge) was the primary complementary food. The use of ugali as the primary complementary food suggests that the children may be at risk of inadequate micronutrient intake among children 12-23 months. These findings underscore the need to establish solutions to increase dietary diversity and to promote use of foods that are rich in nutrients such as iron.
Amaranth grain offers the prospect of considerably improving dietary food diversification in semi arid areas. Agronomic investigations indicate that amaranth grain contains high iron concentrations ranging from 7.6-27 mg/100g of edible portion. Amaranth grain is a hardy crop and can withstand low rainfall. As such, grain amaranth may offer a viable solution in semi-arid areas where iron rich foods such as animal and fortified products are not readily available.
This study has therefore been designed to investigate the efficacy of porridge made from amaranth enriched maize flour in improving the diet quality and iron intake in children 12-59 months in a semi-arid area in Kenya. Home fortification of complementary foods using micronutrient powders has also been shown to reduce iron deficiency anaemia in many resource-poor settings including Kenya.
Objectives The primary objective of this study is To determine the efficacy of maize porridge enriched with amaranth grain flour on improving iron intake and status in children 12-59 months in a semi arid area in Kenya.
In addition we aim:
- To determine the efficacy of amaranth grain enriched maize porridge compared to maize porridge fortified with micronutrient multi-mix powder (MixMe™) to improve iron status and intake of children 12-59 months.
- To determine the iron, zinc and nutritional status of children 12-59 months.
Hypothesis
We hypothesize that:
- Children receiving amaranth grain enriched maize porridge will show greater improvement in iron status than those receiving plain maize porridge.
- Children receiving amaranth enriched maize porridge will show less improvement in iron status than those receiving maize porridge fortified with micronutrient multi-mix powder (MixMe™).
Study Area and Population The study will be conducted in Migwani within the larger Mwingi District in Eastern Kenya. This area falls within the arid and semi arid area (ASAL) and thus experiences food shortage for most part of the year. The study population will comprise children aged 12-59 months. Mothers or principal caretakers will be interviewed on behalf of the children.
Study Design The study will have a randomized controlled trial design conducted over a period of 4 months/16 weeks.
The administrative study area has been purposively selected as it falls within an agro-ecological zone of a semi-arid area. Random sampling out of a total of six Sub-locations in Migwani will be done to get 4 Sub-locations. Within a Sub-location, individual sampling units (Household with a child aged 12-59 months) will be selected using a random walk method until the required sample size of 68 children is achieved per Sub-location. Children who meet the inclusion criteria shall be randomly assigned to one of the following treatment groups:
- Maize porridge enriched with amaranth grain flour
- Maize porridge fortified with a multiple micronutrient powder (MixMe™)
- Plain maize porridge
- Conditions
- Anemia, Iron Deficiency Anemia
- Being tested
- Maize and Amaranth
- Keywords
- Complementary foods, Amaranth, Food Based approaches, Iron Deficiency anemia, Arid Areas, Africa
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maize and AmaranthDietary supplement
Also called Mix Me micro-nutrient powder
80g porridge per day, 5 days a week, for 16 weeks (4 months)
| Study group | Role | What they receive |
|---|---|---|
| Maize porridge with Amaranth | Experimental | Maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio (80g/day) Receives: Dietary Supplement: Maize and Amaranth |
| Maize flour with multiple micronutrients | Active comparator | Maize porridge fortified with a multiple micronutrient powder (MixMe™) Receives: Dietary Supplement: Maize and Amaranth |
| Maize Porridge | Placebo comparator | Plain maize porridge group Receives: Dietary Supplement: Maize and Amaranth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Hemoglobin (g/l)
Measured: Start of study (T=0), End of study (T=4months)
Secondary outcomes (1)
Iron Status
Serum Ferritin microgram/l), serum Transferrin Receptor (mg/l)
Measured: Begin (t=0), End of study (t=4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nairobi, Nestlé Foundation, Nevin Scrimshaw International Nutrition Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224535
- Sponsor's protocol ID
- Amaranth
- Other IDs
- 10/15
- Status last verified
- Oct 2010
- First submitted
- 18 Oct 2010
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hotz C, Gibson RS. Complementary feeding practices and dietary intakes from complementary foods amongst weanlings in rural Malawi. Eur J Clin Nutr. 2001 Oct;55(10):841-9. doi: 10.1038/sj.ejcn.1601239.
PubMed 11593345Macharia-Mutie CW, Moretti D, Van den Briel N, Omusundi AM, Mwangi AM, Kok FJ, Zimmermann MB, Brouwer ID. Maize porridge enriched with a micronutrient powder containing low-dose iron as NaFeEDTA but not amaranth grain flour reduces anemia and iron deficiency in Kenyan preschool children. J Nutr. 2012 Sep;142(9):1756-63. doi: 10.3945/jn.112.157578. Epub 2012 Jul 18.
PubMed 22810982
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Iron Status of Children in a Semi-arid Area of Kenya: the Potential of Amaranth Grain Flour
- ClinicalTrials.gov ID
- NCT01224535
- Acronym / sponsor ID
- Amaranth
- Conditions
- Anemia, Iron Deficiency Anemia
- Keywords
- Complementary foods, Amaranth, Food Based approaches, Iron Deficiency anemia, Arid Areas, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- University of Nairobi, Nestlé Foundation, Nevin Scrimshaw International Nutrition Foundation
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Iron deficiency anaemia remains a significant public health challenge. Localized food based approaches may offer a large opportunity to improve lives and address the widespread micronutrient deficiencies such as iron in affected households. Viable solutions where iron rich foods are not readily available may come through diversification approaches using foods such as amaranth grain reported to contain high iron content and good quality protein in conjunction with the use of in-home fortification.
Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on improving diet quality, iron intake and status in children 12-59 months in a semiarid area in Kenya.
Study population: The study population will comprise children aged 12-59 months in Migwani, within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed on behalf of the children. In total, 270 children will be enrolled in the study.
Study design:
The study has a randomized controlled trial design conducted over a period of 4 months/16 weeks.
Treatment/hypothesis: All participating children will be required to take the provided porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant difference in hemoglobin and iron status between the three groups.
Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive protein (CRP) will be done at the participating laboratories.
Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are the secondary outcome. Iron deficiency will be defined as SF concentration <12 µg/L and tissue iron deficiency will be defined as serum transferrin receptor concentration of >8.3mg/L. Infection will be assessed by raised CRP (>10mg/L) as an indicator of acute inflammation and presence of malaria.
Detailed description
Background and Rationale The most severe problems of micronutrient deficiency are found amongst resource poor, food insecure and vulnerable households in developing countries. From the 1999 Kenya national survey on micronutrients, it was estimated that seven out of every ten children under five years are likely to be anaemic (Hb<110g/L) and nearly half (43.2%) were iron deficient.
The period of complementary feeding is a critical and vulnerable time in the growth and development of children. Poor complementary feeding practices combined with chronic food insecurity are found to substantially contribute to the widespread multiple micronutrients deficiencies in developing countries.
A recent food consumption study in Mwingi district in Kenya, showed that ugali (stiff maize porridge) was the primary complementary food. The use of ugali as the primary complementary food suggests that the children may be at risk of inadequate micronutrient intake among children 12-23 months. These findings underscore the need to establish solutions to increase dietary diversity and to promote use of foods that are rich in nutrients such as iron.
Amaranth grain offers the prospect of considerably improving dietary food diversification in semi arid areas. Agronomic investigations indicate that amaranth grain contains high iron concentrations ranging from 7.6-27 mg/100g of edible portion. Amaranth grain is a hardy crop and can withstand low rainfall. As such, grain amaranth may offer a viable solution in semi-arid areas where iron rich foods such as animal and fortified products are not readily available.
This study has therefore been designed to investigate the efficacy of porridge made from amaranth enriched maize flour in improving the diet quality and iron intake in children 12-59 months in a semi-arid area in Kenya. Home fortification of complementary foods using micronutrient powders has also been shown to reduce iron deficiency anaemia in many resource-poor settings including Kenya.
Objectives The primary objective of this study is To determine the efficacy of maize porridge enriched with amaranth grain flour on improving iron intake and status in children 12-59 months in a semi arid area in Kenya.
In addition we aim:
- To determine the efficacy of amaranth grain enriched maize porridge compared to maize porridge fortified with micronutrient multi-mix powder (MixMe™) to improve iron status and intake of children 12-59 months.
- To determine the iron, zinc and nutritional status of children 12-59 months.
Hypothesis
We hypothesize that:
- Children receiving amaranth grain enriched maize porridge will show greater improvement in iron status than those receiving plain maize porridge.
- Children receiving amaranth enriched maize porridge will show less improvement in iron status than those receiving maize porridge fortified with micronutrient multi-mix powder (MixMe™).
Study Area and Population The study will be conducted in Migwani within the larger Mwingi District in Eastern Kenya. This area falls within the arid and semi arid area (ASAL) and thus experiences food shortage for most part of the year. The study population will comprise children aged 12-59 months. Mothers or principal caretakers will be interviewed on behalf of the children.
Study Design The study will have a randomized controlled trial design conducted over a period of 4 months/16 weeks.
The administrative study area has been purposively selected as it falls within an agro-ecological zone of a semi-arid area. Random sampling out of a total of six Sub-locations in Migwani will be done to get 4 Sub-locations. Within a Sub-location, individual sampling units (Household with a child aged 12-59 months) will be selected using a random walk method until the required sample size of 68 children is achieved per Sub-location. Children who meet the inclusion criteria shall be randomly assigned to one of the following treatment groups:
- Maize porridge enriched with amaranth grain flour
- Maize porridge fortified with a multiple micronutrient powder (MixMe™)
- Plain maize porridge
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maize porridge with Amaranth | Experimental | Dietary Supplement: Maize and AmaranthMaize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio (80g/day) |
| Maize flour with multiple micronutrients | Active comparator | Dietary Supplement: Maize and AmaranthMaize porridge fortified with a multiple micronutrient powder (MixMe™) |
| Maize Porridge | Placebo comparator | Dietary Supplement: Maize and AmaranthPlain maize porridge group |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 12-59 months at the time of entry into the study
- Resident in village for at least 6-months and the caretaker plans to remain in the area for the next year
- Apparently healthy at the time of entry into the study
Key exclusion criteria (4 listed)
- Severe anaemia i.e. Hb concentration <70 g/L (See section 5.5)
- Taking iron containing haematinic supplements
- Transfused in the last six months
- Severely undernourished i.e. anthropometric indices <-3 Z score
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maize and AmaranthAlso: Mix Me micro-nutrient powder80g porridge per day, 5 days a week, for 16 weeks (4 months) | Dietary supplement | Maize Porridge, Maize flour with multiple micronutrients, Maize porridge with Amaranth |
Primary outcome
Hemoglobin
Time frame: Start of study (T=0), End of study (T=4months)
Hemoglobin (g/l)
1 secondary outcome
Iron Status
Time frame: Begin (t=0), End of study (t=4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2011.
- Background: PubMed 11593345Hotz C, Gibson RS. Complementary feeding practices and dietary intakes from complementary foods amongst weanlings in rural Malawi. Eur J Clin Nutr. 2001 Oct;55(10):841-9. doi: 10.1038/sj.ejcn.1601239.
- Derived from this study: PubMed 22810982Macharia-Mutie CW, Moretti D, Van den Briel N, Omusundi AM, Mwangi AM, Kok FJ, Zimmermann MB, Brouwer ID. Maize porridge enriched with a micronutrient powder containing low-dose iron as NaFeEDTA but not amaranth grain flour reduces anemia and iron deficiency in Kenyan preschool children. J Nutr. 2012 Sep;142(9):1756-63. doi: 10.3945/jn.112.157578. Epub 2012 Jul 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maize and Amaranth in people with Anemia and Iron Deficiency Anemia, run by Wageningen University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: Start of study (T=0), End of study (T=4months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01224535, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2011.